Atrial Fibrillation (AF)IMAGE-AFNCT06735001
Identification of the Metabolic Signature of Atrial Fibrillation for Personalized Prevention
A study testing FA ablation and Lab test in people with Atrial Fibrillation (AF), run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Atrial fibrillation (AF) is a major public health problem. The efficacy of the existing techniques is limited in the more aggressive forms. It is therefore necessary to develop approaches, in particular the identification of relevant biomarkers, to prevent the onset, recurrence or progression of AF in at-risk… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- FA ablation and Lab test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2025to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, all genders, and ethnic origins
- Free, informed, and written consent signed
- Person affiliated to or benefiting from a social security scheme
Who cannot join
- Age < 18 years
- Lack of informed consent
- Gestating women (pregnancy test carried out as part of care for FA patients, contraception, or menopause for women in control groups)
- Persons under administrative or judicial protection
- Endocarditis or pericarditis in progress or within the 3 last months
- Active tumor pathology (benign or malignant)
Show all 9Show fewer
- Chronic inflammation or autoimmune disease
- Chronic liver disease
- Myocardial infarction within the last 8 weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital of Bordeaux
Pessac, 33604
Nicolas DERVAL, +33 5 56 79 56 79, nicolas.derval@chu-bordeaux.fr
Lorena SANCHEZ BLANCO, +33 5 57 62 30 91, lorena.sanchez-blanco@chu-bordeaux.fr
About this study
Atrial fibrillation (AF) is a major public health problem. The efficacy of the existing techniques is limited in the more aggressive forms. It is therefore necessary to develop approaches, in particular the identification of relevant biomarkers, to prevent the onset, recurrence or progression of AF in at-risk patients. The objective of this study is to describe the longitudinal metabolic and biomolecular signature of AF in patients eligible for cardiac ablation.
Read the detailed description
Atrial fibrillation (AF) is a major public health problem. Its prevalence exceeds 2%. The main aim of drug treatment is to prevent the onset of stroke and heart failure, but side effects often require discontinuation, and contraindications limit their use. Rhythm control strategies based on catheter ablation have led to significant progress in incident AF, improving quality of life. Nevertheless, the efficacy of these techniques is limited in the more aggressive forms. Significant recurrence rates are reported one year after ablation, and access to them is often reserved for symptomatic patients due to their invasive and costly nature.
It is therefore necessary to develop approaches to prevent the onset, recurrence or progression of AF in at-risk patients. While the pathophysiology of AF involves metabolic remodelling that can be observed in animal and human models, no clinically relevant metabolites have been identified as biomarkers of the risk of AF onset or progression, with a view to preventive and personalized management.
In response to this unmet need, this project aims to develop a method for assessing the risk of AF recurrence, combining the identification of a metabolic signature of the arrhythmia and the patient, with a machine learning approach to aggregate conventional risk factors and metabolic biomarkers. A longitudinal clinical study will be conducted on patients scheduled for AF ablation, to monitor changes in their metabolic signature over 12 months, in parallel with arrhythmia progression. Using machine learning, the study team will establish and validate a classifier retrospectively stratifying patients with or without recurrent AF, and compare this method with canonical risk stratification. This will enable to consider personalized management of patients at risk of recurrence, with the aim of reducing human and economic costs.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- FA ablation, Lab test
- Keywords
- atrial fibrillation, prevention, biomarkers, cardiac metabolism
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FA ablationProcedure or surgery
Ablation of the FA
Lab testBiological
Blood collection
| Study group | Role | What they receive |
|---|---|---|
| Patients with FA | Other | Patient with a documented Fibrillation Atrial within the last 18 months Receives: Procedure: FA ablation; Biological: Lab test |
| Patients without FA | Other | Patient without Fibrillation Atrial Receives: Biological: Lab test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers T1
The individuation of biomarkers uniquely present in AF patients - compared to control groups.
Measured: Day 0
Biomarkers T2
The individuation of biomarkers uniquely present in AF patients - compared to control groups.
Measured: Day 1
Biomarkers 2
The identification of biomarkers predictive of the risk of AF recurrence
Measured: 12 months
Secondary outcomes (2)
Algorithm
Identification of the machine learning algorithm with the best predictive performance for AF recurrence
Measured: Month 12
Atrial electroanatomy and apneas
Existence of correlation between atrial electroanatomy and apneas accompanied by desaturation
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start10 Mar 2025
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- prospective multicentric study
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas DERVAL, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735001
- Sponsor's protocol ID
- CHUBX 2024/01
- Other IDs
- 2024-A00416-41
- Acronym
- IMAGE-AF
- Status last verified
- May 2026
- First submitted
- 21 Nov 2024
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Metabolic Signature of Atrial Fibrillation for Personalized Prevention
- ClinicalTrials.gov ID
- NCT06735001
- Acronym / sponsor ID
- IMAGE-AF / CHUBX 2024/01
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- atrial fibrillation, prevention, biomarkers, cardiac metabolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atrial fibrillation (AF) is a major public health problem. The efficacy of the existing techniques is limited in the more aggressive forms. It is therefore necessary to develop approaches, in particular the identification of relevant biomarkers, to prevent the onset, recurrence or progression of AF in at-risk patients. The objective of this study is to describe the longitudinal metabolic and biomolecular signature of AF in patients eligible for cardiac ablation.
Detailed description
Atrial fibrillation (AF) is a major public health problem. Its prevalence exceeds 2%. The main aim of drug treatment is to prevent the onset of stroke and heart failure, but side effects often require discontinuation, and contraindications limit their use. Rhythm control strategies based on catheter ablation have led to significant progress in incident AF, improving quality of life. Nevertheless, the efficacy of these techniques is limited in the more aggressive forms. Significant recurrence rates are reported one year after ablation, and access to them is often reserved for symptomatic patients due to their invasive and costly nature.
It is therefore necessary to develop approaches to prevent the onset, recurrence or progression of AF in at-risk patients. While the pathophysiology of AF involves metabolic remodelling that can be observed in animal and human models, no clinically relevant metabolites have been identified as biomarkers of the risk of AF onset or progression, with a view to preventive and personalized management.
In response to this unmet need, this project aims to develop a method for assessing the risk of AF recurrence, combining the identification of a metabolic signature of the arrhythmia and the patient, with a machine learning approach to aggregate conventional risk factors and metabolic biomarkers. A longitudinal clinical study will be conducted on patients scheduled for AF ablation, to monitor changes in their metabolic signature over 12 months, in parallel with arrhythmia progression. Using machine learning, the study team will establish and validate a classifier retrospectively stratifying patients with or without recurrent AF, and compare this method with canonical risk stratification. This will enable to consider personalized management of patients at risk of recurrence, with the aim of reducing human and economic costs.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective multicentric study
| Arm | Type | Receives |
|---|---|---|
| Patients with FA | Other | Procedure: FA ablation, Biological: Lab testPatient with a documented Fibrillation Atrial within the last 18 months |
| Patients without FA | Other | Biological: Lab testPatient without Fibrillation Atrial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years, all genders, and ethnic origins
- Free, informed, and written consent signed
- Person affiliated to or benefiting from a social security scheme
Key exclusion criteria (9 listed)
- Age < 18 years
- Lack of informed consent
- Gestating women (pregnancy test carried out as part of care for FA patients, contraception, or menopause for women in control groups)
- Persons under administrative or judicial protection
- Endocarditis or pericarditis in progress or within the 3 last months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FA ablationAblation of the FA | Procedure or surgery | Patients with FA |
| Lab testBlood collection | Biological | Patients with FA, Patients without FA |
Primary outcome
Biomarkers T1
Time frame: Day 0
The individuation of biomarkers uniquely present in AF patients - compared to control groups.
Biomarkers T2
Time frame: Day 1
The individuation of biomarkers uniquely present in AF patients - compared to control groups.
Biomarkers 2
Time frame: 12 months
The identification of biomarkers predictive of the risk of AF recurrence
2 secondary outcomes
Algorithm
Time frame: Month 12
Atrial electroanatomy and apneas
Time frame: Immediately after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation (AF)
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
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CONVERGE Post-Approval Study (PAS)
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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas DERVAL principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FA ablation and Lab test in people with Atrial Fibrillation (AF), run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guido CALUORI (+33 5 35 38 19 58, guido.caluori@ihu-liryc.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers T1 (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.